The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasional Gastrointestinal Issues

Not Applicable

Recruiting

• Conditions: Gastrointestinal Microbiome; Nutrition, Healthy; Exercise

• Registration Number: NCT06564285
• Lead Sponsor: Athletic Greens International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following<br>criteria:<br><br> - Provide voluntary signed and dated informed consent.<br><br> - Does not have any chronic health conditions that could impact participation in this<br> study such as oncological or psychiatric disorders.<br><br> - No known history of chronic illness or disease.<br><br> - Aged between 18 and 60 years (inclusive).<br><br> - Body Mass Index of 20-34.9 (inclusive).<br><br> - Agree to maintain existing dietary and physical activity patterns throughout the<br> study period.<br><br> - Willing and able to comply with the study protocol.<br><br> - Self-reported gastrointestinal symptoms, such as self-reported abdominal pain, gas<br> and bloating after meals, heartburn/acid reflux after meals, and issues with<br> digestion.<br><br> - Must be in good general health.<br><br> - Following a stable, consistent diet pattern.<br><br> - Agree to refrain from any lifestyle changes that may affect their GI tract and IBS<br> symptoms for the duration of the study.<br><br> - Not currently taking and not planning on introducing any product, supplement or<br> medication aimed at gut health or nutritional gaps during the study period.<br><br> - Resides in the United States.<br><br>An individual who meets the following criteria will be excluded from participation in<br>this study:<br><br> - Prior prescriptions for IBS or any other medication (OTC and prescription) targeting<br> the gut.<br><br> - Taking any supplements targeting the gut in the past 30 days.<br><br> - Current IBS treatment (e.g. proton pump inhibitors, laxatives).<br><br> - Follow an extreme diet intervention. This includes specific exclusion-type diets<br> like vegan, vegetarian, carnivore, paleo, Atkins, ketogenic etc.<br><br> - Experienced significant weight loss (10% total body weight) in the past 3 months<br> prior to study participation.<br><br> - Usage of any medication or herbal remedies which can affect the GI tract.<br><br> - Food intolerances/allergies.<br><br> - History of GI tract cancers.<br><br> - Celiac disease/gluten intolerance.<br><br> - Pregnant women, women trying to conceive, women less than 120 days postpartum, or<br> nursing women.<br><br> - Anyone with any allergy requiring the use of an Epi-pen.<br><br> - Multivitamin/Multimineral supplement consumption within the past 3 months.<br><br> - History of use of medications or dietary supplements known to confound the study or<br> its endpoints.<br><br> - History of unstable or new-onset cardiovascular, liver, or renal conditions.<br><br> - History of diabetes or endocrine disorder.<br><br> - Anyone who has received an antibiotic, antifungal, antiparasitic, or antiviral<br> treatment within 90 days prior to the study.<br><br> - Excessive alcohol consumption (more than 2 standard alcoholic drinks per day or more<br> than 10 drinks per week) within the past 6 months.<br><br> - Current smokers or smoking within the past month.<br><br> - History of drug abuse or dependence.<br><br> - History of hyperparathyroidism or an untreated thyroid condition.<br><br> - History of malignancy in the previous 5 years except for non-melanoma skin cancer<br> (basal cell cancer or squamous cell cancer of the skin).<br><br> - Prior gastrointestinal bypass surgery (Lapband, etc.).<br><br> - Other known gastrointestinal or metabolic conditions that might impact nutrient<br> absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses,<br> history of colon resection, gastroparesis, and Inborn errors of metabolism (such as<br> PKU).<br><br> - Diagnosed chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's,<br> ulcerative colitis, Lupus, HIV/AIDS, etc.).<br><br> - Previous medical diagnosis of asthma, gout, or fibromyalgia.<br><br> - A change in hormone therapy, including oral contraceptives, within 4 weeks prior to<br> screening, or unwilling to maintain current hormone therapy/oral contraceptive use<br> throughout the course of the study.<br><br> - Known allergy or sensitivity to any ingredient in the test formulations as listed in<br> the product label or in the placebo ingredients.<br><br> - Currently participating in another research study with an investigational product or<br> have been in another research study in the past 30 days or planning on taking part<br> in another research study during this study's duration.<br><br> - Has undergone any surgery or invasive treatments in the previous six months or has<br> any planned for during the study period.<br><br> - Anyone taking any supplements that have the same ingredients as those in the test<br> product.<br><br> - Has taken a probiotic, prebiotic, or postbiotic in the past 30 days.<br><br> - Currently taking any opioid medications such as oxycodone (OxyContin®), hydrocodone<br> (Vicodin®), codeine, morphine, or kratom.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut Microbiome;Nutrient Gaps;Digestive Measures;GI Symptoms